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NDC 49314-2083-03 Unishield Sinus Decongestant 10 mg/1 Details
Unishield Sinus Decongestant 10 mg/1
Unishield Sinus Decongestant is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unishield. The primary component is PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 49314-2083-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 49314-2083 |
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Product ID | 49314-2083_da55994d-b70c-29c0-e053-2995a90a2e0e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Unishield Sinus Decongestant |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Phenylephrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
Substance Name | PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | Unishield |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 49314-2083-03 (49314208303)
NDC Package Code | 49314-2083-3 |
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Billing NDC | 49314208303 |
Package | 100 PACKET in 1 BOX (49314-2083-3) / 1 TABLET, FILM COATED in 1 PACKET |
Marketing Start Date | 2021-03-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b8f68d9d-2d38-414a-e053-2a95a90a15ec Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Do not use
■ If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Unishield Sinus Decongestant Label
Unishield
Sinus Decongestant
Phenylephrine HCl 10 mg
100 Tablets/ 1 Tablet Per Packet
Pseudoephedrine Free Sinus Relief
Pull To Open
• For sinus headache, pain, pressure, and congestion
Compare active ingredients to:
Sudafed PE®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
INGREDIENTS AND APPEARANCE
UNISHIELD SINUS DECONGESTANT
phenylephrine hcl tablet, film coated |
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Labeler - Unishield (790677053) |
Registrant - Unifirst First Aid Corporation (832947092) |